我院118例中成药不良反应报告分析

Analysis of 118 ADR Cases of Chinese Patent Medicines in Our Hospital

目的了解我院中成药不良反应(ADR)发生的特点及一般规律。方法对我院2006年1月—2008年12月各科室上报的ADR报告中的118份中成药ADR进行归类、分析。结果 118例中成药ADR监测报告中,中成药ADR的高发年龄段为41～80岁之间,共81例(占总例数的68.65%,下同);发生率最高的给药途径是口服给药,共102例(86.44%);中成药引发ADR的药品种类中发生率前3位的依次是清热剂(21.67%)、祛湿剂(15.83%)、祛瘀剂(15.00%);主要临床表现为皮肤及附件损害(36.76%)、消化系统损害(31.62%)、神经系统损害(18.38%)等;其中严重不良反应为32例(27.12%);所有症状在停药、改用其它药物和治疗后消失或缓解,无一例患者死亡。结论提倡合理使用中成药,加强中成药ADR的监测、报告、诊断和处理对确保安全用药至关重要。

OBJECTIVE To probe into the characteristics and regularity of adverse drug reaction （ADR） of Chinese patent medicines occurred in our hospital. METHODS A total of 118 ADR cases of Chinese patent medicines reported by clinical departments from Jan 2006 to Dec 2008 were classified and analyzed. RESULTS Patients aged from 41 to 80 were likely to have ADR. 86.44% of the ADR cases of Chinese patent medicines were induced by oral medication administration. Topping the list in terms of the incidence of ADR of Chinese patent medicines in descending order were antipyretic agent （21.67%）, dampness-dispelling formula （15.83%） and blood-stasis-removing formula （15.00%）. The ADR manifested mainly as lesions of skin and its appendants （36.76%）, damage of digestive system （31.62%） and damage of nervous system （18.38%） etc. Thirty-two patients had severe adverse reactions （accounted 27.12%）. All symptoms disappeared or relieved after drugs withdrawal or change to other drugs or treatment, no patients died. CONCLUSION It should be promoted to use Chinese patent medicines reasonably. To strengthen the monitoring, reporting, diagnosis and treatment of ADR of Chinese patent medicines is of utmost importance.